HR 13594 · 95th Congress · Drug industry
Food and Drug Reform Act
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to House Committee on Interstate and Foreign Commerce.(1978-07-25)
Plain Language Summary
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Food and Drug Reform Act - Amends the Federal Food, Drug, and Cosmetic Act to eliminate the testing of new drugs and new animal drugs for effectiveness. Requires a label on such a drug stating that it has not been tested or reviewed for efficacy by the Federal Government. Reduces the reporting requirements on applications for new drugs and new animal drugs to require only a summary, not a full report, on each investigation, and to prohibit any required submission of such a report within four years of the date of submission of the application. Requires the Secretary of Health, Education, and Welfare, prior to issuing, amending or repealing any regulation under such Act, to issue a comprehensive economic impact statement addressing specified questions. Requires semiannual reports to Congress on the status of each new drug and new animal drug application which has not been approved or disapproved 30 days before such submission. Establishes drug advisory committees which shall promptly review an application and submit recommendations to the Secretary within 90 days. Grants applicants the right to a mandatory review within 30 days after receiving an adverse recommendation. Requires the …
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (12)
3 Democrats9 Republicans